5-FU/Cisplatin, Gemcitabine May Be Effective Options for Invasive Bladder Cancer
This study was designed to evaluate the efficacy of each treatment using 3-year distant metastasis–free survival as a primary outcome.
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Editor's note: This article was updated to correct an error in the definition of DM3. DM3 is the rate of distant metastasis at 3 years.
Twice-daily radiation plus 5-fluorouracil/cisplatin (FCT) and once-daily radiation plus gemcitabine (GD) may be effective therapeutic options for patients with muscle-invasive bladder cancer, according to research being presented at the 2018 Genitourinary Cancers Symposium in San Francisco, California.1
For the phase 2 NRG/RTOG 0712 study (ClinicalTrials.gov Identifier: NCT00777491), researchers randomly assigned 66 patients with T2-4a bladder cancer who had undergone maximal transurethral resection and induction chemoradiotherapy to receive FCT (33 patients) or GD (33 patients).
The study was designed to evaluate the efficacy of each treatment using the rate of distant metastasis at 3 years (DM3) as a primary outcome. Secondary outcomes included the complete response (CR) rate and bladder intact distant metastasis–free survival at 3 years (BI-DMFS3). The median follow-up was 4.3 years.
In the FCT arm, the DM3 was 22%, BI-DMFS3 was 67%, and the CR rate was 88%. Nearly all patients in the FCT arm (97%; 32) completed induction, 93% (27) completed induction and consolidation, and 55% (18) reached the end of the treatment protocol.
For the GD arm, DM3 was 16%, BI-DMFS3 was 72%, and the CR rate was 78%. Among patients in the GD group, 94% (31) completed induction, 92% (32) completed induction and consolidation, and 49% (16) completed treatment.
Grade 3 to 4 adverse events (AEs) were reported among 64% (21) and 55% (18) of patients in the FCT and GD groups, respectively, including hematologic, gastrointestinal, and genitourinary AEs.
The authors concluded that these “regimens are promising, given DM3 rates < 25%. As there was less toxicity in the GD arm, it would be reasonable to consider a gemcitabine based option as well as a cisplatin based regimen for future trials. Daily radiation may be as effective as twice-daily radiation, which may broaden appeal.”
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- Coen JJ, Zhang P, Saylor PJ, et al. Selective bladder preservation with twice-daily radiation plus 5-flourouracil/cisplatin (FCT) or daily radiation plus gemcitabine (GD) for patients with muscle invasive bladder cancer: primary results of NRG/RTOG 0712—a randomized phase 2 multicenter trial. Oral presentation at: 2018 Genitourinary Cancers Symposium; February 8-10, 2018; San Francisco, CA.